JP2007500541A - Otoscope - Google Patents

Abstract

  An otoscope that allows examination of a patient's ear is characterized by an instrument head having a proximal end and a distal insert that can be inserted into the ear. The otoscope has an imaging lens array disposed in the instrument head, and each imaging lens array, the eyepiece, and the distal opening of the distal insertion portion are arranged along the optical axis. Further, the otoscope has a focus mechanism for selectively interlocking at least one imaging lens array and an eye provided on the eyepiece along the optical axis. The imaging lens array and the eye in the eyepiece define the optical system so that the entrance pupil is located substantially within the distal insertion portion of the instrument head so that the entire eardrum can be observed by the user at one time. To.

Description

  The present invention relates to the general technical field of otoscopes, and more particularly to an otoscope apparatus that is improved and capable of selective focus adjustment.

  An otoscope is a hand-held instrument that is generally known in the field of medical diagnostic instruments, mainly among specialists or health care providers who examine a patient's ear, mainly the eardrum.

  A typical otoscope has an instrument head with a distal frustoconical insertion site that can be held by a specialist and can be worn to overlay a disposable speculum tip. Further, it is desirable that the disposable spectroscopic tip is designed in a truncated cone shape so that it can be inserted into the hole of the patient's ear by an appropriate distance. Usually, the optical fiber curly hair is wrapped around the distal end opening of the insertion portion so as not to disturb the visualization of the object by the user, and the fiber is a small incandescent lamp provided in the neck portion of the handle or the head. Or it extends from a contained light source, such as a light bulb. The target (eg, tympanic membrane) is then observed through a lens located at the proximal end of the instrument head, which lens and the distal tip opening of the insert to allow viewing by the user. It is optically aligned. Often, the lens magnifies the target image.

  Alternatively, a video camera or at least one solid-state imager, such as a CCD or CMOS-based imager, can be used in place of the lens to inspect the target, and the processed image is sent to a video monitor for display. Sent. Furthermore, the instrument head can also be equipped with a pneumatic valve receiving port, allowing air blowing (eg, compressed air otoscopy). In addition, in some cases, these devices can be used not only for examining the nose and throat in addition to the ear and ear canal, but also for general illumination and magnification systems.

  There are many things that are currently considered necessary in this area. When considering the basic function of an otoscope, such as the visualization of the eardrum, it was necessary to express that in addition to pupil distance, increasing the field of view, giving it a greater magnification. The pupil distance is actually defined as the distance between the nearest eye of the device (eg, the lens closest to the doctor's eye) and the specialist / user's eye when viewing the full field of view. Magnification and pupil distance are interrelated, and having an overly magnified image will result in an image that is “closer” to the physician's eyes. With current otoscopes, the entire eardrum cannot be brought into the field of view due to the tortuous ear canal and the lenses used therein.

  In order to achieve all these improvements, in general, all of the above factors are related and therefore require a depth of field tradeoff. For example, loss of depth of field will cause the eardrum to become out of focus for some patients with long or short ear canals (compared to so-called standard or nominal ear canals). This lack of focus is a significant disadvantage and has a significant impact on the physician's ability to deliver proper treatment.

Furthermore, there is a need in the field that various diagnostic procedures can be performed as part of a wide range of otoscope examinations. This need places increasing demands and constraints on the removably attached disposable spectroscopic tips used in the device to maintain cleanliness and prevent cross-contamination. A brief list of requirements that characterize these types of otoscope chips includes:
i) achieve optimal field of view (eg straighten the ear canal, maximize clear aperture);
ii) collecting light coming back from the eardrum so that the eardrum can be effectively illuminated and the part visible.
iii) to provide an effective and substantial fluid tight seal not only on the ear, but also on the instrument head to allow air blasting (eg, pneumatic oscilloscope);
iv) for earwax (earwax), allowing certain tools to be placed and used while looking through the optics;
v) allowing multiple chips to be stacked in a compact form to facilitate storage in a dispenser or toolbox;
vi) sufficiently cost-effective manufacturing conditions to make the chip disposable or replaceable;
vii) prevent secondary contamination;
viii) Adapt to many patient types (eg, provide multiple sizes);
ix) minimizing the risk of unsafe insertion into a typical ear;
x) Match the relevant otoscope used.

In order to meet these very extensive lists of requirements, any currently known otoscope chip is optimized for only one or two of the above characteristics, or some of them Obviously, it will be done reasonably. As a result, there are disadvantages, particularly with respect to the design of currently available disposable speculum tips.
US Patent Application Publication No. 2003/0063386 US Pat. No. 6,190,310B1 US Pat. No. 6,213,938B1 US Pat. No. 6,383,133B1 US Pat. No. 5,363,839 US Pat. No. 6,142,934 US Pat. No. 6,511,420B1 US Pat. No. 6,554,765B1

  Therefore, one main object of the present invention is to provide an otoscope device that solves the above-mentioned problems and the deficiencies of the prior art.

  Another main object of the present invention is to provide at least one or a group of otoscope chips that provide an optimal solution to the above-mentioned problems with a minimum number of otoscope chips. This objective is particularly important not only when doctor / specialist consultation room space can be a problem, but also in the logic or other issues (such as cross-contamination) that arise in relation to managing a large number of different chips. It is.

  Yet another object of the present invention is to provide an otoscope instrument that provides not only a larger field of view of the target but also an appropriate magnification, thereby allowing the entire eardrum to be observed from an appropriate working distance.

  Yet another major object of the present invention is to provide an otolaryngological instrument that includes an adjustable optical system that allows selective focusing by a physician without compromising performance or effectiveness. That is.

  Yet another major objective of the present invention is to reduce the amount of time normally required for focusing, particularly in situations that are impractical for some patients (eg, moving children). It is an object of the present invention to provide an otoscope having a single focus position capable of substantially covering a typical eardrum distance.

  Still another main object of the present invention is that, if necessary, a CCD or an equivalent image sensor can be added to realize a digital autoscope, and the above-mentioned focusing position is taken. It is to provide an otoscope with an optical system that makes possible.

Thus, according to a first preferred feature of the present invention, an otoscope capable of examining a patient's ear,
i) an instrument head having a proximal end and a distal axisymmetric insert insertable into the ear;
ii) observation means proximate to the proximal end of the instrument head;
iii) an imaging lens array disposed in the instrument head, wherein each of the imaging lens array, the observation means, and the distal opening of the insertion portion is arranged side by side along the optical axis,
iv) Provided with a focus mechanism that selectively moves at least one of the imaging lens array and the observation unit along the optical axis with respect to the imaging lens array.

  According to the preferable modification, the focus mechanism selectively moves the observation unit along the optical axis with respect to the captured image sequence. Preferably, the imaging lens array is disposed in a tube member, and the focusing mechanism includes a rotating member whose rotation causes translational movement of lenses (optics) provided in the observation means. The otoscope may include display means to indicate the relative position of the observation means, which is preferably an eyepiece containing at least one optical element therein.

  Preferably, the focus mechanism may be repeatedly set to a preferred focus position that can be used by the physician, depending on the patient's physical characteristics, his / her characteristics to be observed, and / or other factors. And other focus settings can be made.

  For example, by adjusting the focus mechanism by means of a rotary knob located on the eyepiece, the user can not only achieve both greater magnification and field of view, but also correct the focus position to the object distance. it can. Alternatively, the focusing mechanism includes a rotating sleeve member that can also be accessed by the user through a window located on the opposing horizontal side of the instrument head. The indicating means may further include a detent to indicate when a preferred focus position has been achieved.

  The imaging lens array of this application and the eyes of the observation means define the optical system. The instrument optical system described herein has an entrance pupil located substantially within the instrument's distal insert, allowing a wider field of view than conventional otoscopes. According to one variant, an aperture stop is arranged in the system for optics in order to form a junction for both the entrance pupil and the exit pupil of the system.

According to another preferred feature of the invention, in an otoscope that allows examination of a patient's ear, the otoscope comprises:
i) an instrument head having a proximal end and a distal insert inserted into the patient's ear;
ii) observation means attached to the proximal end of the instrument head;
iii) an imaging lens array disposed in the instrument head distal to the observation means;
iv) The imaging image sequence and the observation means having an entrance pupil arranged substantially close to a distal tip opening of the insertion portion of the instrument head, wherein the imaging lens sequence is configured to observe the image. The imaging lens array is capable of capturing the entire eardrum at one time and relaying the image of the eardrum through the observation means.

According to another preferred feature of the present invention, there is provided a method of manufacturing an otoscope instrument having an instrument head provided with a distal insertion portion,
i) providing an observation means proximate to the proximal end of the instrument head;
ii) providing an imaging lens array disposed in the instrument head, wherein the imaging lens array, each of the observation means, and the distal opening of the insertion section are aligned along the optical axis And
and iii) providing a focus mechanism for selectively moving at least one of the imaging lens array and the observation unit along the optical axis.

Also according to another preferred feature of the invention,
A distal insert inserted into the ear, the distal insert having an instrument head having a distal opening;
An optical system housed in the instrument head, the optical system comprising an entrance pupil and an observation means for observing an image of a target of interest aligned along the optical axis having the distal aperture. And wherein the entrance pupil is provided comprising an entrance pupil located proximate to the distal opening of the instrument head proximate its distal opening.

  One advantage of the present invention is that the devices described herein can be used without requiring further training by a physician.

  Another advantage of the present invention is that the current device can be utilized according to a fixed focus setting used by the majority of patients, or alternatively and selected as needed, depending on certain factors. In other words, the focus position can be corrected.

  Another advantage of the present invention is that the doctor can observe the entire tympanic membrane without panning the instrument, thereby improving the examination time, especially when the patient's ear is infected and painful. To reduce painful testing procedures.

  The effect further obtained by the device of the present invention is that one hand can be operated in any direction.

  These and other objects, features and advantages will be readily apparent from the following detailed description which should be read in conjunction with the accompanying drawings.

  The following description relates to the best embodiment of an otoscope manufactured according to the present invention and the best embodiment of a disposable, releasably attachable otoscope tip element design. However, there are many variations and modifications apparent to those skilled in the art that can implement the embodiments of the invention described below.

  Furthermore, some terms such as distal, proximal, apex, bottom, “front”, “rear”, clockwise, counterclockwise, etc. are used in the description of the invention to facilitate reference to the accompanying drawings. However, these terms do not necessarily refer to limitations of the invention, except as very rigorously pointed out.

  As shown in FIG. 1, the otoscope denoted by reference numeral 10 has a cylindrical handle portion 14, and the handle portion 14 is a set of batteries (not shown) held in a built-in battery compartment (not shown). (Not shown). The handle portion preferably has a removable bottom 17 to allow battery replacement. The handle portion 14 allows the instrument 10 to be held by hand and has a top that is sized to receive an instrument head 18 attached thereto. The instrument head 18 is substantially hollow to accommodate the insufflation port 28, which has a proximal end 22 and opposite, an axisymmetric distal insert 29 shown in FIG. Characterized by opposed distal ends 26 having. The handle portion 14 further has a start button 23 disposed on the bottom portion 17 which selects the illumination output of the illumination portion incorporated in the neck or throat portion of the instrument head 18 as well as the device. It is used to power up the rheostat 25 to be adjusted. It should be noted that each of the features related to the handle described above are known in the art and need no further explanation with respect to the present invention.

  Before describing the remaining more detailed forms of the otoscope 10 more specifically, a preferred disposable speculum that is mounted to cover the distal axisymmetric insert 29 of the instrument 10 and FIGS. Special reference is made to the tip element 40. The tip element 40 is preferably made of a castable plastic material such as polypropylene and has a pair of open ends, ie, a narrow distal end 44 that tapers outwardly with respect to a wider proximal end 48. Defined by a substantially axisymmetric shape having The proximal end 22 also has several non-axisymmetric features, which will be described in detail below.

  For purposes of the following discussion, the tip element 40 shown in FIGS. 2-5 represents an adult-sized tip, ie, a tip that is inserted into an adult patient's ear. However, each tip has several tip elements 40, both outside and inside, so that the tip element 40 can be attached to the otoscope, particularly to the distal axial insert 29 of FIG. 6, regardless of the subject patient. Usually has an inset structure. It will be readily appreciated that the tip is made so that it can be resized by the patient.

  In addition to the foregoing, each tip element 40 of the present application has a large distal opening, which extends a greater distance into the patient's ear canal by any previously known disposable tip element of that size. be able to.

  Referring to FIG. 15, a representative tip element has been experimentally determined to have critical dimensions based on the anatomy of the ear canal and the conical structure of the distal axisymmetric insert 29 of the instrument 10. . By increasing both the inner diameter of the distal end of the tip element 40 and the length of that portion of the tip element that can be inserted into the ear, better access to the tympanic membrane and its better appearance can be obtained. . To illustrate this, a comparison between an adult-sized chip element 40 manufactured according to the present invention and a child chip element 40A, together with known chip elements 40 ', 40A' of the same type, is shown in FIG. Given as shown. First, each tip element 40, 40 ', 40A, 40A' has a pair of surfaces; the first surface is the scope 10 from the proximal end of each tip element to the intermediate interface indicated by -I-. The second conical surface is a conical surface extending from the intermediate interface -I- to the distal tip opening. Each of the present chip elements 40, 40A is substantially longer than the intermediate interface, thus allowing the chip to extend a greater distance into the patient's ear canal. Furthermore, the distal tip opening of each tip element 40, 40A is wider compared to the depicted conventional tip design 40 ', 40A'. The main difference between each is the overlay of each of the tip elements 40, 40A, 40 ', 40A' represented on each of the existing otoscope cones manufactured according to the present invention and the inserts manufactured according to the present invention. Together with this, it is shown in a table in FIG.

  Returning to FIGS. 2-5, each tip element 40 has a plurality of external engagements positioned relative to the proximal open end 48 of the tip element, regardless of the intended patient (eg, child, adult, etc.). It has a feature 52. According to this particular embodiment, three such features 52 are provided equidistant from each other about every 120 degrees on the circumference, provided that the actual number of engagement features 52 provided is Can be easily changed. Each outer engagement feature 52 according to this embodiment extends radially from the open proximal end 48 of the tip element 40 and substantially forms an L-shape with an outer peripheral fixing portion 55 and an axial portion 54 depending on it. The outer peripheral fixing portion 55 has a plurality of teeth 56 located on the engagement surface. Further, the outer peripheral fixing portion 55 is substantially V-shaped, and the portion has the maximum thickness at the interface with the dependent axial portion 54 and is tapered at the opposite end. It has a minimum thickness, thereby having a sloped engagement surface. The dependent axial portion not only allows stacking of a plurality of tip elements 40 but also provides a gripping surface when the tip elements are mounted on the otoscope. A plurality of spaced apart axial ribs 66 disposed between each of the dependent axial portions are also gripped when mounting the tip element 40, as will be described in more detail in a later section. Give the surface.

  The inner surface 60 of the tip element 40 described herein is polished to improve light transmission, and more preferably has an angled inner protrusion 64 located near the proximal tip opening. . Referring to FIG. 5, the tip element 40 also has an inner annular seal ring 70 that helps in sealing the tip element to the conical portion of the distal axisymmetric insert 29 of the instrument head 18. Preferably, it is provided for inhalation.

  With reference to FIGS. 6 and 7, the instrument head 18 overlies the distal axisymmetric insert 29 and allows the releasable attachment / detachment of the tip element 40 to the instrument 10. Holds several elements, including the disposable tip element 40 described above.

  The device 10 described above can be used for compressed air otoscopy to the insufflation port 28 of FIG. 7 via a hose coupling 272, partially shown in FIG. The bond extends to a well-known air supply (not shown).

  Within the limitations of the instrument head 18 and starting with a distal axisymmetric insert and extending proximally along a defined optical axis 27 is an imaging train that includes a predetermined number of optical elements, most of which Is disposed in the cylindrical member 80 at the open end. The tube member 80 has a variable diameter defined here with three axial sections, each axial section having a different inner diameter. The first shaft section 84 of the tube member 80 is defined by the inner diameter at its distal end, is defined by the inner diameter of its distal head, and is such that the ends of the subject, or adjacent each other, overlap. It has a size for holding the lens 96 and the lens 100 arranged in relation. The lens 96 and the lens 100 are provided close to each other, and the target distal lens 96 partially extends from the largest opening at the end of the tube member 80. According to the present embodiment, the second shaft section of the tube portion 88 has an inner diameter larger than the diameter of the first shaft section, and the second shaft sections are arranged at appropriate intervals. The first relay lens 104, the aperture stop 98, and the second relay lens 112 are connected to a third shaft section. The diameter of the third shaft section of the tube member 80 is larger than the diameter of the first shaft section 84 and the second shaft section 88. The function of the imaging column and the function of the entire optical system of the form 10 described here will be discussed later.

  Returning to the overall assembly of the instrument 10, the tube member 80 is held in an internal front assembly 116 that is also located in the instrument head 18, where the first shaft 84 of the tube member 80 is It is sized to fit within the distal axisymmetric insert 29. Inner front assembly 116 provides support for tube member 80 and further provides a means for a plurality of optical fibers (not shown) extending from illumination assembly 124. Referring to FIG. 6, the lighting assembly 124 fits within the neck or throat of the instrument head 18, the lighting assembly having a small incandescent lamp 128, which is in the base 136. And is connected to it via a lamp holder 140, each of which is held in a cylindrical sleeve member 144. A bumper guard 146 is disposed on the top of the incandescent lamp 128 to protect the lens envelope. The electrical connection of the lighting assembly to a battery (not shown) provided in the handle portion 14 of FIG. 1 and the interconnection to the rheostat 25 of FIG. 1 are generally known and It does not constitute an essential part.

  Preferably, the first shaft portion 84 of the tube member 80 is within the distal axisymmetric insert 29 such that the distal objective lens 96 is proximal to the distal opening, as shown in FIG. Adapted, the tube member and the surrounding inner front assembly 116 are placed through an opening in the instrument head sized to receive them. Preferably, the tube member 80 is sealed to the proximal end of the inner front assembly 116 using a suitable adhesive, where a portion of the third shaft section 92 extends therefrom. The seal shown as 150 in FIG. 7 is in close proximity to the insufflation port 28 so that air can be infused into the air supply, such as through a hose joint 272, shown in part in FIG. (For example, behind). In other words, the air entering the insufflation port must flow forward (eg, towards the insert and distal tip) and the seal must be beyond the insufflation port and toward the proximal end Means.

  As shown more specifically in FIGS. 6, 7, 13, and 14, the eyepiece mechanism 160 is held at the proximal end 48 of the instrument head 18, which is proximate its rectangular distal end 172. A substantially cylindrical lens carrier member 164 with a set of external screws 168 disposed therein is included. The rectangular distal end 172 of the lens carrier member 164 is sized to fit the corresponding opening 180 of FIG. 7 and is provided within the instrument head that holds the lens carrier member 164 and prevents rotational movement of the member. It has been. A tube-shaped lens holding member 176 is provided by the corresponding screw portion 186, 184 on the inner distal end of the lens holding member and on the outer side of the proximal end of the lens carrier member 164, respectively. The member 164 is firmly fixed. The lens holding member 176 is sized to receive a pair of optical lenses 190 and 194, and when the lens holding member and the lens carrier member are assembled to the instrument head, they are arranged along the optical axis 27 of FIG. Above it includes an interior in which the optical elements 96, 100, 104, 112 of the imaging row are also arranged side by side. The eyepiece mechanism 160 further includes a wave spring 192 and a lens holding member 196 that are respectively disposed between the lens 190 and the lens carrier member 164. Further, the spacer 195 is disposed between the lenses 194 and 190, and the O-ring 199 is used to seal the lens 194 with the lens carrier member 176.

  With reference to FIGS. 6, 7, and 12, the outer thread 168 of the lens carrier member 164 is provided 1 on the inner surface of a cylindrical focusing sleeve member 200 that is fitted thereon in an overlying relationship. Engages with a set of corresponding threads 207. The focusing sleeve member 200 has an axial length that extends to project from the proximal end 48 of the instrument head 18 when the sleeve member is attached. A soft grippable elastomeric cover 202 covers the shank of the sleeve member 200, which is mounted to rotate with the sleeve member to the end of the transition determined by the protrusion 203. The ball 204 and compression spring 206, shown only in FIG. 7, are each disposed within the interior of the instrument head 18 and each is a single indentation formed on the outside of the focusing sleeve member 200 (FIG. The springs form a rotation stop that biases the ball and informs the user that the focus position preset by the manufacturer has been reached. Focusing knob 208 is a fastener attached to the proximal end of focusing sleeve member 200. The focusing knob 208 has a central opening 212 so that the user / doctor observes the object along the aligned optical axis 27 so that each of the focusing sleeve member 200 and the lens holding member 176 respectively. And allows selective axial adjustment of the eyepiece mechanism 160 of FIG. 13 for the imaging row via the rotational movement of the sleeve 200. Preferably and during assembly, the lens holding member 176 is adjusted relative to the lens carrier member 164. This adjustment allows, for example, factory settings for people with a certain focal length, and different factory settings for veterinary use with a longer default focus position, where the sleeve position is Simply adjust above or below this position.

  For the purpose of adjustability, the instrument head 18 further has a pair of windows 21 as shown in FIGS. 8 and 9, which are formed on their opposite horizontal sides, where the sleeve member For example, as shown in FIGS. 8 and 9, the axial portion of the soft grippable elastomer cover 202 with respect to 200 is easily accessible to the user in addition to the focus knob 208.

  The chip actuator mechanism of the instrument 10 will be described in detail with reference to FIGS. 2 to 5, 10, 11, 18 (a), and 18 (b). This mechanism includes a tip element retainer member 240 that is stably attached to the distal end of the instrument head 18, which retainer includes a plurality of circumferentially spaced slots 242. In the present embodiment, three slots 242 are provided, where two of the slots have two circumferentially inclined surfaces 244. Each of the inclined surfaces 244 has a set of teeth for mating with teeth 56 provided on the external engagement tab 52 of the tip element 40. The tip actuator mechanism further includes a rotatable actuator knob 252 biased by means of a spring 256 that passes through a slot 264 in the actuator knob 252 and into a hole 268 provided in the retaining member 240. It has an axial first end 260 extending therethrough. The remaining end 269 of the spring 256 fits within a slot 270 formed on the actuator knob 252. The holding member 240 is attached to the front facing surface of the rotatable actuator knob 252 and the actuator knob further does not have a circumferentially inclined surface 244 from the front facing surface. Pin 254 extending into 242 is included.

  In operation, the otoscope tip element 40 as described above is mounted on the distal end of the instrument head 18, and more particularly in an overlying relationship with the distal axisymmetric insert 29, and the external engagement feature 52. Each of the circumferential securing portions 55 is fitted in a circumferential slot 242 provided in the chip element holding member 240. The tip element 40 is then twisted clockwise in this example to engage the two teeth 56 of the wedge-like engagement feature with the corresponding inclined surface 244 of the tip element holding member 240, thereby While providing positive engagement, and providing the tip element 40 to the instrument 10, it provides a comfortable feel to the user.

  Referring to FIGS. 10, 11, 18 (a), and 18 (b), to release the tip element 40 from the instrument 10 after patient examination, the actuator knob 252 is preferably mounted on the actuator knob 252. Rotates in the counterclockwise direction indicated by indicator 261 located on the outer surface. This causes a rotational movement of the knob 252 relative to the stationary tip element holding member 240, and the front facing pin 254 moves its slot 242 without the inclined surface 244, causing the tip element 40 to move into the slot of the holding member 240. To the rotating enemy to release the chip element.

  The design of the tip element 40 described here is fairly universal; that is, the tip element is not only compatible with the instrument 10 described herein, but also many existing US Pat. Fits many existing otoscopes, such as the bayonet type attachment method described in US No. 387, and those using a discharge type mechanism described in US Pat. No. 4,366,811 The entire contents of each of the above patents are incorporated herein by reference.

  In operation, the use of the focus mechanism allows the optics of the eyepiece mechanism 160 to move relative to the imaging column of the instrument 10. The focusing sleeve member 200 and the soft grippable elastomer cover piece 202 allow each to rotate about the optical axis 27, while the lens carrier member 164 and the attached lens holding member 176 have an instrument head 18. It can only move linearly by a fixed connection with the rotation. The remaining portion of the optical imaging row, including the front objective lens 96, disposed in the tube member 80 is in a stationary state, thus allowing rotational movement to be achieved and making focus adjustments possible. As described above, the engagement of the ball into the recess of the focusing sleeve member 200, biased by the compression spring, is a predetermined fixed focus position (preset position, or , The distance between the eyepiece lens and the remaining optical elements of the stationary imaging row in the tube member 80).

  Indicating this preset, or other focus position, is accomplished by means of a visual indicator 209 provided on the outside of the grippable elastomer cover 202, the portion of the cover being replaced by the focus knob 208. A soft grippable cover 202 is accessible through a window 21 formed on the horizontal side of the instrument head 18 to allow selective rotational movement of the focusing mechanism.

  The scale of the marker 213 is coupled to a detent and further on the instrument head proximate to the window 21 including a preset focus position marker 215 that can be placed alongside a visual indicator 209 that indicates the preferred nominal focus position of the instrument 10. It is formed on the edge portion.

  For a given fixed focal position according to this embodiment, the total length of the entire imaging system (ie, the distance between the most distal and most proximal optical surface including the eyepiece optics) is 77. 60 mm, the magnification is 1.63X when the eardrum is located at a working distance of about 10 mm from the open distal end 44 of the speculum tip element 40, and the depth of field is about 3-5 mm It is. Furthermore, the nominal pupil distance is about 21.5 mm.

  7 and 19, the aperture stop 108 is optically joined to both the entrance pupil 8 and the exit pupil 9 of the entire optical system. The axial position and the size of the entrance pupil 8 are critical in achieving an unobstructed view of the entire eardrum, as schematically shown as 6 in FIG. If the entrance pupil 8 located far from the lens 96 is too close to the lens, the end of the tip element 40 causes an excessive blockage of the light emitted from the upper edge of the eardrum 6. If the exit pupil is located far away from the lens 96, it is now time to leave the eardrum 6 from the upper edge of the eardrum 6 by the edge of the first or last optical surface of the lens 96 and lens 100. Cause excessive blockage of light rays. In the present embodiment, the exit pupil 8 is located close to the objective double lens (the lens 96 and the lens 100) so as to achieve an optimal view of the eardrum 6 with minimum light shielding. . Similar considerations apply to the physical size of the aperture stop 108.

  The exit pupil 9 is located closest to the lens 194 and at a proximity position of about 21.5 mm with respect to the optical surface. This distance a) obtains an optimal view of the eardrum 6 with minimal light blockage, a) optimal image stability related to the horizontal movement of the user's eyes during ear examination, and c ) Provides the ability to accommodate a wide range of optical lenses. The position of the exit pupil with respect to the lenses 190 and 194 is constant regardless of the position of the focusing mechanism.

  The optical system described herein can be easily extended to video / imager human otoscopy by adding an electronic imaging assembly 304 on the proximal end of the otoscope, as shown in FIG. Furthermore, the devices described here can likewise be used for veterinary otoscopy based on optical or video / imaging elements as well. Furthermore, by using an appropriate optical adapter, the optical system shown here can be modified easily and conveniently, for example by adding optical elements to the observation means shown in the preceding embodiments. .

  Movement for selective focusing of the lenses 190 and 194 of the eyepiece mechanism gives the user a close-up view (important in infant ear examination) and a distal view (important in throat and nose examination). Give. The working distance between the eardrum 6 and the first optical surface of the distal lens 96 is optimized to be around 27 mm according to the present embodiment; this latter dimension is that of the dropping drop This is clinically important because it gives an accurate setting during insertion of the tube into the ear canal too deep. Furthermore, the optical system described here generates a normal image of the eardrum to the user at the viewing means.

  The imaging column substantially places the objective doublet lenses 96, 100 in the ear during examination. This is because the optical element is located in the most distal portion of the instrument head 18 and is closer than any typical otoscope. As a result, a larger (ie, wider) field of view is achieved, ie, an area larger than the area of the eardrum can be observed by the user at the operating position of the device. Further, the position of the entrance pupil allows an unobstructed view of a typical adult eardrum for a working distance of about 27 mm or more, where the working distance is the distance between the eardrum and the lens 96. As a space separated from the distal surface, or according to the present embodiment, it is about 9.5 mm from the eardrum to the distal end of the tip element 40. Using the optical system described herein, the entire eardrum can be observed without creating a field of view greater than about 9 mm at a working distance of about 33 mm, without having to shoot the instrument 10 around the camera. The separation between the optical element housed in the tube member 80 and the eyepiece optical element 190, 194 allows focusing within an appropriate range of working distances and ease of use for the user. It is variable to allow compensation for. As a result, an appropriate tradeoff between magnification, field of view, working distance, pupil distance, and focus range is achieved. The latter parameter is additionally critical so that the device can be further used, for example, for examination of a patient's throat or nose.

  An additional problem associated with otoscopes, particularly with respect to the style of imaging with optical elements located within the main line of sight, is the insertion of an instrument in the ear while looking through the optical elements. Is that it is very difficult to do this. Diagnostic otoscopes and others allow the magnifying window to move to the side or out of the way, but the resulting view is typically highly disturbed. Using a curette through a limited area is far from ideal.

  Referring to FIG. 16, the mounting chip 280 and the curette 284 will be described below to deal with the above problem. For example, as described above, this can be observed through the optical element of the otoscope 10. While doing this, it is a substantially better instrument insertion. The wearing tip 280 according to the present embodiment basically has a cage-like member 290 that extends the tip that contacts the patient from the otoscope, leaving a large open area where the curette 284 can be inserted and manipulated. It is. It will be appreciated that the tip that contacts the patient can take a variety of shapes and sizes since the distance of the cage and the support structure can. In the present embodiment, the cage-like member is defined by three legs 294 extending between the distal ear insert 298 and the proximal otoscope attachment 299, the entire cage-like member being approximately It is 1 inch long. The curette 284 is ideally curved to maximize its ability to manipulate it within the defined open area between the legs 94. Alternative shapes and ranges when some or all of the baskets are reusable or attached together will be readily apparent to those skilled in the art. However, the advantage of a fully disposable version is that the characteristics of instrumentation include exposure and removal of some foreign material from the ear that increases the risk of cross-contamination. It should be noted that the length of the tip and otoscope optics must be aligned so that the area in front of the tip is in focus for use of the device. The otoscope mounting portion 299 preferably includes an external engagement feature, as shown in FIGS. 2-5, or has an internal hood mounting claw, depending on the otoscope tip mounting mechanism used therein. It is preferable.

  Referring to FIG. 17, a further problem with disposable otoscope tips is that they fail to seal the majority of patient ears well. In addition, the soft overmolded tip version seals relatively well, but prevents the polymeric elastic body from being inserted into the ear beyond the depth at which it interferes with the ear. Thus, the tip achieves an effective seal, but prevents or obstructs the intrinsic visualization during air blowing. If the tympanic membrane cannot be seen during this process, the movement (or lack thereof) creates the basis for diagnosis, so sealing or blowing is a practical purpose. Don't be.

  To address the above problems, an elastomer seal accessory that slides on the outside of a disposable tip element, such as those previously described in FIGS. 2-5 or other versions having a substantially conical body 300 is provided according to one embodiment. This elastomer seal accessory 300 provides a good seal against the patient's ear and can adjust its axial position on the tip. Therefore, the chip can be set to a “deeper” insertion or a shallow insertion, and both a seal and proper insertion for visualization can be achieved. The seal accessory 300 is preferably set at the distal end of the tip and is preferably sufficiently flexible to be “pressed” when the physician inserts the tip into the ear canal (not shown).

  Additional features such as markings on the chip and depth setting provide advantages. Since the shape of the elastomer seal accessory 300 itself has a mushroom shape in the present embodiment, the accessory can be crushed to seal various sizes of the external auditory canal. In the case of this mushroom-shaped design, the effect is that these chips are not sensitive to positional variations (ie the accessory can seal at many different locations along the chip). Therefore, the axial position of the accessory can be easily changed along the length of the chip in order to effectively optimize the seal. It will be readily apparent that there are alternative shapes that embody the inventive concept conceived and used herein for the above elastomer seal accessories.

1 is a side view of an otoscope manufactured according to the present invention. FIG. FIG. 2 is an isometric view of a disposable otoscope tip element used in conjunction with the otoscope of FIG. 1. FIG. 3 is a front view of the otoscope tip element of FIG. 2. FIG. 4 is a side view of the otoscope tip element of FIGS. 2 and 3. FIG. 6 is a rear view of the otoscope tip element of FIGS. FIG. 6 is a cross-sectional side view of the instrument head of the otoscope of FIG. 1 through line 6-6 of FIG. FIG. 7 is a cross-sectional plan view of the instrument head of FIG. FIG. 8 is a front perspective view of the instrument head of FIGS. 6 and 7. 9 is a rear perspective view of the instrument head of FIGS. 6-8. FIG. FIG. 3 is a partial front perspective view of an otoscope tip release actuator assembly. FIG. 11 is an exploded view of the chip opening actuator assembly of FIG. 10. FIG. 10 is a partially exploded view of a focus sleeve used in the otoscope of FIGS. 1 and 6 to 9. FIG. 10 is an exploded view of an eyepiece mechanism used in the otoscope of FIGS. 1 and 6 to 9. It is sectional drawing of the eyepiece lens mechanism of FIG. FIG. 6 is a partial cross-sectional side view showing various design variations to certain known chip element designs. 1 is a side view of an instrument tip element made in accordance with one aspect of the present invention. FIG. 6 shows an elastomer assembly that can be mounted on the chip element of FIGS. FIG. 18A shows a partial front view of the otoscope tip discharge mechanism shown at two operation positions. FIG. 18B shows a partial front view of the otoscope tip discharge mechanism shown at two operation positions. FIG. 3 is a ray tracing diagram of an optical system of an otoscope instrument according to a preferred embodiment. It is a side view of the instrument head with which an electronic imaging device used as observation means is used instead of the eyepiece lens mechanism.

Claims (36)

In an otoscope that allows examination of a patient's ear,
The otoscope is
i) an instrument head having a proximal end and a distal insert insertable into the ear;
ii) observation means proximate to the proximal end of the instrument head;
iii) an imaging lens array disposed in the instrument head, wherein each of the imaging lens array, the observation means, and the distal opening of the insertion portion is arranged side by side along the optical axis,
iv) a focus mechanism that selectively moves at least one of the imaging lens array and the observation unit along the optical axis;
An otoscope characterized by that. The otoscope according to claim 1,
The focus mechanism selectively moves the observation means along the optical axis with respect to the imaging lens array;
An otoscope characterized by that. In the otoscope according to claim 2,
The imaging lens array is disposed in a tube member, the focus mechanism has a rotating member, and causes the translational movement of the observation means by rotation of the rotating member.
An otoscope characterized by that. In the otoscope according to claim 2,
Display means for displaying a relative position of the observation means;
An otoscope characterized by that. In the otoscope according to claim 4,
The display means has a preset focus position marker indicating that the focus mechanism is set to a preferred nominal focus position;
An otoscope characterized by that. In the otoscope according to claim 2,
The focus mechanism includes a detent that stops the observation means back to at least one predetermined axial position.
An otoscope characterized by that. The otoscope according to claim 1,
The observation means is an eyepiece having at least one optical element, and the eyepiece is attached to a proximal end of the instrument head.
An otoscope characterized by that. The otoscope according to claim 1,
The observation means has an electronic imaging device,
An otoscope characterized by that. In the otoscope according to claim 5,
The focus mechanism includes detent means for detenting the observation means to at least one predetermined axial position, and the at least one predetermined axial position is the preferred nominal focus position.
An otoscope characterized by that. The otoscope according to claim 1,
Having at least one optical adapter that can be mounted in the vicinity of the observation means;
An otoscope characterized by that. The otoscope according to claim 1,
The imaging lens array and the observation means define an optical system having a distal entrance pupil and a relay lens system;
An otoscope characterized by that. The otoscope according to claim 7,
The imaging lens array is disposed in the tube member,
The focus mechanism has a rotating member,
Rotation of the rotating member causes translational movement of at least one of the optical elements included in the eyepiece;
An otoscope characterized by that. The otoscope according to claim 11,
The entrance pupil is located proximate to a distal opening of the distal insert of the instrument head;
An otoscope characterized by that. The otoscope according to claim 13,
The optical system creates a field of view greater than about 9 mm for a working distance of about 33 mm, allowing the entire eardrum to be visualized by the viewing means when the otoscope is used for ear examination. ,
An otoscope characterized by that. The otoscope according to claim 1,
The imaging lens array and the observation unit generate a normal image.
An otoscope characterized by that. The otoscope according to claim 7,
The eyepiece has at least one magnifying eye;
An otoscope characterized by that. The otoscope according to claim 12,
The instrument head has at least one window disposed intermediate the eyepiece and the distal insert;
The window allows the means for rotating the rotating member to adjust the focus mechanism;
An otoscope characterized by that. The otoscope according to claim 17,
Display means for displaying a relative movement of at least one of the optical elements in the eyepiece;
The display means has a scale of a preset position indicator,
An otoscope characterized by that. The otoscope according to claim 18, wherein
The scale of the preset position indicator is arranged close to at least one of the windows,
An otoscope characterized by that. In an otoscope that allows examination of a patient's ear,
The otoscope is
i) an instrument head having a proximal end and a distal insert inserted into the patient's ear;
ii) observation means attached to the proximal end of the instrument head;
iii) an imaging lens array disposed in the instrument head distal to the observation means;
iv) The imaging lens array and the observation means having an entrance pupil arranged in proximity to a distal tip opening of the insertion portion of the instrument head, and the imaging lens array relays an image to the observation means The imaging lens array can capture the entire eardrum at once, and relays the image of the eardrum through the observation means.
An otoscope characterized by that. The otoscope according to claim 20,
The observation means includes an eyepiece, and the eyepiece includes at least one magnifying eye.
An otoscope characterized by that. The otoscope according to claim 22,
The imaging lens array is disposed in a tube member.
An otoscope characterized by that. The otoscope according to claim 21,
The otoscope produces a field of view of about 9 mm or greater for a working distance of about 33 mm between the distal insert and a target;
An otoscope characterized by that. The otoscope according to claim 21,
The imaging lens array and the observation unit generate a normal image.
An otoscope characterized by The otoscope according to claim 20,
The observation means has at least one electronic imaging device,
An otoscope characterized by that. In a method of manufacturing an otoscope instrument having an instrument head provided with a distal insert,
i) providing an observation means proximate to the proximal end of the instrument head;
ii) providing an imaging lens array disposed in the instrument head and arranged along the optical axis together with the observation means and the distal opening of the insertion part;
iii) providing a focus mechanism for selectively interlocking at least one of the imaging lens rows and the observation unit along the optical axis;
An otoscope manufacturing method characterized by the above. The method of manufacturing an otoscope according to claim 26.
Further comprising providing at least one preset focus position for setting the furcus mechanism to at least one predetermined desired focus position;
An otoscope manufacturing method characterized by the above. The method of manufacturing an otoscope according to claim 26.
Providing means for indicating to the user when the focus mechanism is set to a desired focus position;
An otoscope manufacturing method characterized by the above. The otoscope manufacturing method according to claim 28,
The display means has a detent mechanism.
An otoscope manufacturing method characterized by the above. An instrument head having a distal opening and having a distal insert inserted into the ear;
An optical system housed in the instrument head and having an entrance pupil and an observation means for observing an image of a target of interest arranged along the optical axis alongside the distal aperture;
The entrance pupil is disposed proximate to the distal opening of the distal insertion portion of the instrument head proximate its distal opening;
An otoscope characterized by that. The otoscope of claim 30, wherein
The optical system comprises at least one lens disposed in the distal insert; a relay lens between the at least one lens and the observation means;
An otoscope characterized by comprising. The otoscope of claim 31, wherein
A pair of relay lenses, and an aperture stop disposed between the relay lenses,
The aperture stop is arranged to form the entrance pupil in the ear when the distal insert is inserted into a patient's ear.
An otoscope characterized by that. The otoscope of claim 30, wherein
The observation means includes an eyepiece mechanism disposed at a proximal end of the instrument head.
An otoscope characterized by that. The otoscope according to claim 33,
The eyepiece mechanism has at least one enlarged eye;
An otoscope characterized by that. The otoscope of claim 30, wherein
The observation means is an electronic imaging device;
Otoscope characterized by The otoscope of claim 30, wherein
The observation means has at least one optical element,
The otoscope comprises means for selectively changing the position of the at least one optical element of the observation means for changing the focus of the optical system;
An otoscope characterized by that.

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